NCT07182591 A Study of DS5361b in Participants With Advanced Solid Tumors
| NCT ID | NCT07182591 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Daiichi Sankyo |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2025-10-02 |
| Primary Completion | 2030-03-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 192 participants in total. It began in 2025-10-02 with a primary completion date of 2030-03-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.
Eligibility Criteria
Key Inclusion Criteria: The clinical site will screen for the full inclusion criteria per protocol. 1. Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old). 2. Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with standard treatment or for which no standard treatment is available (For Part 1 and Part 2 only). 3. Participants need to have documented TMB or MSI status using a validated or approved genomic test as per applicable regulations prior to Cycle 1 Day 1. In Part 1 and Part 2, participants need to have documented TMB-H and/or MSI-H status. In Part 3, participants need to have documented TMB-H status. 4. Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. 6. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention. 7. For HNSCC participants only: have documented results from local testing of HPV for oropharyngeal cancer. If HPV status has previously been tested using this procedure, no retesting is required. Dose Expansion (Part 3) Only: 8. Has histologically or cytologically confirmed, Stage IV NSCLC without actionable gene alteration. * No prior systemic therapy. * Participants with PD-L1 TPS ≥1%. 9. Has histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies. * No prior systemic therapy administered in the recurrent or metastatic setting. * Participants with PD-L1 CPS ≥1. Key Exclusion Criteria: 1. Has spinal cord compression or clinically active central nervous system metastases. 2. Has a history of leptomeningeal carcinomatosis. 3. Uncontrolled or significant cardiovascular disease. 4. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event. 5. Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out. 6. Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen). 7. Has any evidence of severe or uncontrolled systemic diseases. 8. Has active or uncontrolled HBV infection. Hepatitis B SCR testing is required. 9. Has active or uncontrolled HCV infection. Hepatitis C SCR testing is required. 10. For the dose escalation phase (Part 1 and Part 2), has HIV infection. For the dose expansion part (Part 3), has active or uncontrolled HIV infection. 11. Prior organ transplantation, including allogeneic stem cell transplantation. 12. Has an active, known, or suspected autoimmune disease. 13. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07182591 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07182591 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07182591 currently recruiting?
Yes, NCT07182591 is actively recruiting participants. Contact the research team at CTRinfo_us@daiichisankyo.com for enrollment information.
Where is the NCT07182591 trial being conducted?
This trial is being conducted at Sarasota, United States, Providence, United States, Irving, United States, San Antonio, United States and 3 additional locations.
Who is sponsoring the NCT07182591 clinical trial?
NCT07182591 is sponsored by Daiichi Sankyo. The trial plans to enroll 192 participants.